BEUDAMED
    18 results · 39ms · Sources: EU EUDAMED, US FDA

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    K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BioCare Safety Needles

    FDA UDI
    BIOTRONIX HEALTHCARE INDUSTRIES, INC.·00858835007776·Disposable BioGuard Safety Needles 23G x 1 1/2"

    Bernafon

    FDA UDI
    Bernafon AG·05711584087312·ZR1, KIT 312 NFM 85 PB L BE ZERENA 1

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776205034·Lletz Tissue Fcp

    TARGON FN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KDL SYRINGES AND NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNKNOWN

    FDA Adverse Event
    Malfunction ·WILLIAM COOK EUROPE·Product code DTK·March 30, 2016

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 19, 2022

    KYPHON BONE CEMENT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code NDN·April 23, 2019

    1030489-2019-01423

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code NDN·December 13, 2019

    ISOFLEX LEAD

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DTB·January 13, 2014

    DUAL EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 20, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 4, 2011

    OSTEOCOOL RF ABLATION SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code GEI·October 21, 2020

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 15, 2023

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·June 28, 2023

    PUSHING CATHETER

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·March 5, 2021

    Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·November 20, 2013